Paired Psoriasis Lesion, Comparative, Study to Evaluate MOL4239 in Psoriasis

NCT ID: NCT01826201

Last Updated: 2014-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-08-31

Brief Summary

The purpose of this study is to determine whether MOL4239 is effective in adult subjects with mild to moderate plaque psoriasis by comparing two target lesions in which each subject will apply MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days.

Detailed Description

This is a phase 2a, Randomized, Multi-center, Blinded, Paired Psoriasis Lesion, Comparative Placebo-Controlled study to evaluate the safety, preliminary efficacy and pharmacokinetics of MOL4239 in 30 adult subjects with mild to moderate plaque psoriasis. Eligible subject will have a diagnosis of mild to moderate plaque psoriasis affecting 9.9% body surface area (BSA) or less, and two designated similar target lesions with a Psoriasis Severity Score of at least 6 or higher. Each subject will apply 10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days.

Conditions

Psoriasis

Keywords

psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

10% MOL4239 ointment & placebo ointment

10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days

Group Type: EXPERIMENTAL

MOL4239

Intervention Type: DRUG

10% MOL4239 ointment to one target lesion twice a day for 28.5 consecutive days

Placebo

Intervention Type: DRUG

placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days

Interventions

MOL4239

10% MOL4239 ointment to one target lesion twice a day for 28.5 consecutive days

Intervention Type: DRUG

Placebo

placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adults, males or females, 18 to 72 years of age (both inclusive.)
• Mild to moderate plaque psoriasis with lesions that in total are no more than 9.9% BSA and with a baseline Psoriasis Severity Score (PSS) of 6 or more.
• Identification of bilaterally symmetrical or approximately equivalent target lesions of at least 2.5 x 2.5 cm (~6 cm2) on the trunk, arms or legs to mid calf with a Psoriasis Severity Score (PSS) of 6 or greater.
• Willing to avoid tanning devices or exposure of the treated skin to the sun.
• Willing to not use cosmetics, including lotions, creams, and moisturizers on the treated lesions.
• Use of Eucerin® is allowed on all non-test site areas.
• Willing to forgo systemic and other topical treatments for psoriasis during the course of the study.
• Willing to avoid bathing or swimming for two hours after study drug treatment.
• Negative urine pregnancy test at Screening and baseline for women of childbearing potential (WOCP).
• Sexually active WOCP participating in the study must agree to use a medically acceptable method of contraception while on study.
• Must have recovered from the effects of any surgery, other than minor office surgical procedures, and a minimum of 3 months must have elapsed from the day of surgery to the day of screening.

Exclusion Criteria

• Presence of significant abnormalities of liver or renal functions.
• Presence of any clinically significant lab abnormalities at screening.
• Any significant uncontrolled medical disease.
• Use of the anti-tumor necrosis factor (TNF) biologic agents 4 months prior to randomization or use of Stelara 6 months prior to randomization.
• Use, within one month prior to baseline or during the study, of: 1) systemic immunosuppressive drugs (e.g., tacrolimus), or 2) oral meds (e.g. methotrexate, retinoids, etc.).
• Use within one month prior to baseline or during the study of: 1) Systemic corticosteroids, 2) Systemic antibiotics, 3) other systemic antipsoriatic treatment, 4) oral psoralen with ultraviolet A (PUVA) therapy, or 5) ultraviolet B (UVB) therapy.
• Use within two weeks prior to baseline or during the study of: 1) topical anti-psoriatic drugs, 2) topical corticosteroids, 3) other topical retinoids, or 4) topical immunosuppressive agents.
• Current diagnosis of unstable forms of psoriasis in the treatment area, including guttate, erythrodermic, exfoliative or pustular psoriasis.
• Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis vulgaris.
• Females who are pregnant, breast feeding, or planning a pregnancy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Moleculin, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eduardo Tschen, MD

Role: PRINCIPAL_INVESTIGATOR

Academic Dermatology Associates

Javier Alonso-Llamazares, MD

Role: PRINCIPAL_INVESTIGATOR

International Dermatology Research, Inc.

Steven Kempers, MD

Role: PRINCIPAL_INVESTIGATOR

Minnesota Clinical Study Center

Locations

International Dermatology Research, Inc.

Miami, Florida, United States

Minnesota Clinical Study Center

Fridley, Minnesota, United States

Academic Dermatology Associates

Albuquerque, New Mexico, United States

Countries

United States

Other Identifiers

M-02

Identifier Type: -

Identifier Source: org_study_id